Manhattan Pharmaceuticals Completes Enrollment in Phase 2a Study of Oral Oleoyl-estrone for Obesity
February 21 2007 - 8:29AM
PR Newswire (US)
NEW YORK, Feb. 21 /PRNewswire-FirstCall/ -- Manhattan
Pharmaceuticals, Inc. (AMEX:MHA) today announced it completed
patient enrollment in its first Phase 2a multi-center,
international clinical study evaluating the safety and preliminary
efficacy of oral Oleoyl-estrone (OE) for the treatment of obesity.
This randomized, double-blind, placebo-controlled, parallel group
study enrolled 100 patients at two clinical trial sites in the US
and one in Europe. This ongoing Phase 2a study is evaluating obese
adult subjects with a body mass index (BMI) of 27-38.9. Each
subject has been randomized into one of four treatment groups to
evaluate safety, preliminary efficacy, and pharmacokinetics of two
14-day dosing cycles of 5mg, 10mg, or 20mg of oral OE compared to
placebo given once daily during each dosing cycle. Each 14-day
dosing cycle is followed by a 28-day treatment free evaluation
period. In addition to safety and tolerability, this Phase 2a study
is also designed to further evaluate weight loss, maintenance of
weight loss, and other therapeutic outcomes. Manhattan
Pharmaceuticals is also conducting a second Phase 2a clinical study
of OE in morbidly obese male subjects (BMI 40-55) that is currently
ongoing at St. Luke's-Roosevelt Hospital Center, University
Hospital of Columbia University College of Physicians and Surgeons.
F. Xavier Pi-Sunyer, MD, is serving as Principal Investigator. OE
is an orally administered, synthetic form of oleoyl-estrone, a
molecule that exists naturally in the body. Based on extensive
preclinical studies, it is believed to work by a dual mechanism of
action. Centrally, OE appears to act at the brain's hypothalamus,
resetting the body's ponderostat, the "food control center" in the
brain that detects and integrates signals that control both
appetite and metabolic behavior. Peripherally, OE also causes
reduced storage of fat in "white fat" tissue and allows skeletal
muscle to use fat as an alternate energy source. About Manhattan
Pharmaceuticals, Inc. Manhattan Pharmaceuticals, Inc., a
development-stage pharmaceutical company, acquires and develops
proprietary prescription drugs for large, underserved patient
populations. In view of the worldwide obesity epidemic, the company
is developing OE, an orally administered novel therapeutic for the
treatment of both common obesity and morbid obesity. To meet the
needs of other major, underserved medical markets Manhattan
Pharmaceuticals is also developing PTH (1-34), a peptide believed
to be a regulator of epidermal cell growth, for the treatment of
psoriasis, and Propofol Lingual Spray, a convenient, proprietary
lingual spray formulation of propofol, the world's best-selling
general anesthetic, as a sedative-hypnotic for use during
diagnostic and therapeutic procedures.
(http://www.manhattanpharma.com/) Note Regarding Forward-Looking
Statements This press release contains forward-looking statements
within the meaning of the Private Securities Litigation Reform Act
of 1995. Such statements involve risks and uncertainties that could
cause Manhattan Pharmaceutical's actual results to differ
materially from the anticipated results and expectations expressed
in these forward-looking statements. These statements are often,
but not always, made through the use of words or phrases such as
"anticipates," "expects," "plans," "believes," "intends," and
similar words or phrases. These statements are based on current
expectations, forecasts and assumptions that are subject to risks
and uncertainties, which could cause actual outcomes and results to
differ materially from these statements. Among other things, there
can be no assurances that any of Manhattan's development efforts
relating to Oleoyl-estrone and its other product candidates will be
successful. Other risks that may affect forward-looking information
contained in this press release include the possibility of being
unable to obtain regulatory approval of Manhattan's product
candidates, including Oleoyl- estrone, the risk that the results of
clinical trials may not support Manhattan's claims, Manhattan's
reliance on third-party researchers to develop its product
candidates, and its lack of experience in developing and
commercializing pharmaceutical products. Additional risks are
described in the company's filings with the Securities and Exchange
Commission, including its Annual Report on Form 10-KSB for the year
ended December 31, 2005. Manhattan assumes no obligation to update
these statements, except as required by law. Contact: Manhattan
Pharmaceuticals, Inc. Michelle Carroll, Corporate Communications
(212) 582-3950 Redington, Inc. Thomas Redington (203) 222-7399
(212) 926-1733 DATASOURCE: Manhattan Pharmaceuticals, Inc. CONTACT:
Michelle Carroll, Corporate Communications, of Manhattan
Pharmaceuticals, Inc., +1-212-582-3950; or Thomas Redington, of
Redington, Inc., +1-203-222-7399, or +1-212-926-1733, for Manhattan
Pharmaceuticals, Inc. Web site: http://www.manhattanpharma.com/
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